[Federal Register Volume 81, Number 99 (Monday, May 23, 2016)]
[Notices]
[Pages 32330-32332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12008]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-16AJE; Docket No. CDC-2016-0043]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the proposed 
National Health and Nutrition Examination Survey (NHANES) Longitudinal 
Study--Feasibility Component. This project will provide a logistical 
test of proposed survey procedures along with contact, interview, and 
examination rates for a sample of previously examined NHANES 
participants. The information obtained will be used to determine the 
feasibility of conducting future follow-up surveys.

DATES: Written comments must be received on or before July 22, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0043 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Leroy A. Richardson, the Information 
Collection Review Office, Centers for Disease Control and Prevention, 
1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-
7570; Email: [email protected].

SUPPLEMENTARY INFORMATION:  Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also

[[Page 32331]]

requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each new proposed collection, each proposed extension of existing 
collection of information, and each reinstatement of previously 
approved information collection before submitting the collection to OMB 
for approval. To comply with this requirement, we are publishing this 
notice of a proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    The NHANES Longitudinal Study--Feasibility Component--New--National 
Center for Health Statistics (NCHS), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 
242k), as amended, authorizes that the Secretary of Health and Human 
Services (DHHS), acting through NCHS, shall collect statistics on the 
extent and nature of illness and disability; environmental, social and 
other health hazards; and determinants of health of the population of 
the United States. Under this authorization, the National Health and 
Nutrition Examination Surveys (NHANES) have been conducted periodically 
between 1970 and 1994, and continuously since 1999 by NCHS, CDC to 
produce descriptive statistics on the health and nutrition status of 
the general population based on direct physical measurements.
    The increasing prevalence of obesity and chronic diseases, 
including diabetes, cardiovascular and kidney diseases, is an important 
public health issue. If feasible, re-contacting past NHANES 
participants could provide information about changes in their health 
condition, exposure to risk factors, and utilization of healthcare 
since the time of their original NHANES exam, thereby making it 
possible to estimate the incidence of various chronic conditions. The 
survey's extensive baseline data on health conditions, nutritional 
status, risk behaviors, and environmental exposures could further allow 
the identification and monitoring of the impact of these factors on the 
participant's current health status. Planning activities for a future 
longitudinal study of all NHANES examined adults from 2007-2014 have 
been initiated. This study--the NHANES Longitudinal Study, targeted to 
start data collection in 2019 or 2020, will provide data to estimate 
the incidence of selected health outcomes in the U.S. population and 
relative risk related to other baseline data. The data collection 
effort proposed in this announcement is only for the Feasibility 
Component of the NHANES Longitudinal Study. The interview and 
examination content proposed in the Feasibility Component represents 
the core module of the future NHANES Longitudinal Study.
    Not since the NHANES I Epidemiologic Follow-up Study (NHEFS), which 
was also conducted by NCHS, has there been a follow-up of a nationally 
representative cohort to assess the relations between baseline 
clinical, nutritional, and behavioral factors to subsequent morbidity 
and mortality. While NCHS has prior experience conducting the follow-up 
of the NHANES I cohort in 1982-1984, more than 30 years has passed. 
Since then, response rates in major federal surveys have declined and 
obtaining cooperation from the household population has become more 
difficult. Therefore, before attempting to launch a full scale data 
collection effort among all examined adults from NHANES 2007-2014, we 
propose conducting a feasibility study (the NHANES Longitudinal Study--
Feasibility Component) to determine whether previously examined 
participants can be successfully traced, interviewed, and examined. The 
proposed Feasibility Component is comprised of two elements: (1) A 
field feasibility test for the core module of the NHANES Longitudinal 
Study; and (2) a series of targeted methodological tests of additional 
components and procedures.
    An annual sample of 400 respondents (total of 800 participants over 
the 2-year period) will be selected from the 2007-2014 NHANES examinees 
(20 years and older) to participate in the field feasibility test. Of 
these, we expect approximately 11% to be deceased prior to the re-
contact, resulting in a target annual sample of 356 living examinees 
and 44 deceased proxy interview respondents.
    As part of the preparation efforts for a longitudinal study of all 
examined adults from NHANES 2007-2014, up to 375 additional persons per 
year (750 participants over the 2-year period) may be asked to 
participate in targeted tests of proposed methods and procedures such 
as bio-specimen collections, cognitive testing for questions, or 
protocol tests for additional exam components. These targeted tests 
will only occur if resources permit and if tracing and participation in 
the field feasibility test is successful. These targeted methodological 
studies will be conducted with paid volunteers or past NHANES 
participants who are not part of the potential NHANES longitudinal 
study sample (for example, past NHANES participants from the 1999-2006 
cycle).
    Participation in the field feasibility test and the targeted 
methodological studies is completely voluntary and confidential. The 
estimated average burden for the field feasibility test is 42 minutes 
per respondent (1.5 hours per respondent for 356 living participants 
and 40 minutes per respondent for 44 proxy of deceased participants, 
annually). The average burden for the targeted methodological study 
respondents is 1 hour. A two-year approval is requested.
    Demographic information such as name, address, phone numbers, and 
social security number collected in the baseline NHANES will be used to 
locate the sampled 800 field feasibility test participants (annual 
sample of 400). Prior to the re-contact, a review of NHANES-linked 
mortality files will be conducted to assist in determining the vital 
status of sampled participants.
    Trained interviewers will visit the sampled participants at home to 
conduct an in-person interview and a health examination. Information 
that will be collected through the interview

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includes health status and medical conditions, health care services, 
health behaviors, and sociodemographic characteristics. In addition, 
permission for collecting hospital discharge data, including diagnoses 
at discharge and procedures performed during hospitalization will be 
obtained during the interview.
    Following the interview, a health examination will be conducted as 
part of the home visit. The respondent's weight, waist circumference, 
and sitting blood pressure will be measured, and a monofilament 
assessment may be conducted for neuropathy. In addition, blood and 
urine will be collected. Examples of laboratory tests planned include 
hemoglobin A1c from the blood specimen, and albumin and creatinine from 
the urine collection. This proposed project will assess the feasibility 
of conducting these tests and procedures in the home examination 
setting.
    A proxy interview will be conducted via telephone for sampled 
participants who died prior to the re-contact. Information on medical 
conditions and overnight hospital stays since baseline will be 
collected.
    Although permission will be sought from all field feasibility test 
participants, hospitalization records will be obtained only for 120 
participants annually (240 participants over the 2-year period) to 
evaluate the record retrieval protocol for the study cohort among 
different medical facilities. An average of 3 hospital stays per person 
is anticipated among this cohort, therefore, an estimated 360 requests 
(120 persons x 3 stays) will be made annually. The estimated burden for 
hospital record provider is 20 minutes per record.
    There is no cost to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
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2007-2014 NHANES examinees....  Field                        400               1           20/60             133
                                 feasibility
                                 test initial
                                 contact and
                                 appointment
                                 scheduling form.
2007-2014 NHANES examinees....  Field                        356               1               1             356
                                 feasibility
                                 test home visit.
2007-2014 NHANES examinees....  Field                        356               1           10/60              59
                                 feasibility
                                 test home urine
                                 collection.
Proxy of deceased 2007-2014     Field                         44               1           20/60              15
 NHANES examinees.               feasibility
                                 test deceased
                                 proxy interview.
Hospital record providers.....  Field                        360               1           20/60             120
                                 feasibility
                                 test hospital
                                 records form.
Adult volunteers (non-field     Targeted                     375               1               1             375
 feasibility test                methodological
 participants).                  studies.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,058
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-12008 Filed 5-20-16; 8:45 am]
 BILLING CODE 4163-18-P